Centre Brings Advanced Cell and Gene Therapies Under Stricter National Regulatory Framework

The Central Government has amended the Drugs Rules, 1945 to strengthen the regulation of advanced medical technologies by bringing cell and stem cell-derived products, gene therapeutic products and xenografts under the Centrally License Approving Authority (CLAA) framework.

The move is aimed at ensuring uniform regulatory standards across the country while enhancing patient safety and supporting the responsible adoption of emerging healthcare technologies.

Stronger Regulatory Oversight

Under the Drugs and Cosmetics Act, certain high-risk drugs and biological products are regulated jointly by the Central and State authorities through the CLAA framework. These currently include vaccines, large-volume parenterals (IV solutions exceeding 100 ml) and recombinant DNA (r-DNA)-based medicines.

With the latest amendment, the CLAA framework has been expanded to include advanced therapies such as:

• Cell and stem cell-derived products, including regenerative stem cell therapies and CAR-T cell treatments.
• Gene therapeutic products, including gene replacement and gene-editing therapies.
• Xenografts, which are medical products derived from animal tissues, such as heart valves used in human transplantation.

Supporting Emerging Medical Technologies

Advanced cell and gene therapies are increasingly being used to treat serious medical conditions.

Stem cell-based regenerative treatments and CAR-T cell therapies have shown promising results in treating blood cancers such as leukaemia and lymphoma. Gene therapies are being developed to treat inherited genetic disorders as well as several forms of cancer. Xenografts, including animal tissue-derived heart valves, are widely used in cardiology and orthopaedic procedures.

Given the complexity and rapidly evolving nature of these technologies, the government has decided to subject them to enhanced regulatory scrutiny to ensure their safety, quality and efficacy.

Uniform Standards Across India

The inclusion of these products under the CLAA framework will establish a system of joint oversight by the Central Licensing Authority and State Licensing Authorities.

This is expected to ensure consistent regulatory standards across all states, strengthen quality control and improve monitoring of advanced medical products throughout their approval process.

Promoting Innovation While Protecting Public Health

According to the government, the amendment reinforces India’s regulatory framework in line with scientific advancements and international best practices.

The revised rules are intended to strike a balance between encouraging innovation in healthcare and life sciences while ensuring that advanced therapies undergo rigorous regulatory evaluation before reaching patients.

The amendment reflects the government’s continued commitment to safeguarding public health, strengthening regulatory oversight and facilitating the safe adoption of cutting-edge medical technologies in India.

---

Source: PIB

---